Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Goshen Health System
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00408551
First received: December 6, 2006
Last updated: June 30, 2009
Last verified: June 2009
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with internal radiation may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy together with internal radiation works in treating patients with colorectal cancer that has spread to the liver.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Drug: floxuridine Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Multi-Institutional Efficacy and Safety Study of Chemotherapy With Selective Internal Radiation Treatment Using Y-90 Microspheres (CHEMO-SIRT) in Patients With Colorectal Cancer Liver Metastasis |
Resource links provided by NLM:
Drug Information available for:
Floxuridine
Fluorouracil
Calcium Gluconate
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Irinotecan
Irinotecan hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan [ Designated as safety issue: No ]
- Hepatic toxicity [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Therapeutic efficacy based on time from selective internal radiation therapy (SIRT) to in-liver disease progression [ Designated as safety issue: No ]
- Therapeutic efficacy based on the proportion of patients who achieve down-staging among all chemo-SIRT treated patients [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2005 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FOLFOX6
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continously over 46 hours beginning on day 1.
|
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
|
|
Experimental: FOLFIRI
Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1.
|
Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
|
|
Experimental: FUDR
Patients receive floxuridine IV continuously on days 1-14.
|
Drug: floxuridine
Given IV
|
Detailed Description:
OBJECTIVES:
Primary
- Evaluate the tumor response, as measured by total tumor mass, carcinoembryonic antigen (CEA) level, measurable tumor volume by CT scan, and metabolic response by positron emission tomography (PET) scan, in patients with colorectal cancer metastatic to the liver undergoing chemotherapy and selective internal radiation therapy (SIRT) comprising yttrium Y 90 resin microspheres.
- Evaluate the hepatic toxicity of this regimen, as measured by ALT, alkaline phosphatase, and bilirubin levels, in these patients.
Secondary
- Evaluate the therapeutic efficacy of this regimen, using time to in-liver disease progression as an end point, in these patients.
- Evaluate the therapeutic efficacy of this regimen, using down-staging to resectability as an end point, in these patients.
OUTLINE: This is a multicenter study.
Patients receive 1 of the following chemotherapy regimens:
- FOLFOX6: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continously over 46 hours beginning on day 1.
- FOLFIRI: Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1.
- FUDR: Patients receive floxuridine IV continuously on days 1-14. In all chemotherapy regimens, treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients also undergo selective internal radiation therapy (SIRT) comprising yttrium Y 90 resin microspheres on day 2 of chemotherapy course 1 (for patients receiving FOLFOX6 or FOLFIRI chemotherapy regimens) or on day 1, 2, 3, 4, or 5 of course 1 (for patients receiving FUDR chemotherapy regimen). SIRT may repeat in week 10 or 12.
In week 18, patients may undergo surgery if down-staging has occurred or they may receive more chemotherapy.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colorectal cancer* meeting 1 of the following criteria:
- Metachronous metastasis after resection of Dukes A-C (i.e., stage I-III) primary colon cancer with or without adjuvant chemotherapy
- Metachronous metastasis after resection of primary rectal cancer with neoadjuvant or adjuvant chemotherapy
- Synchronous metastatic liver disease with symptomatic or asymptomatic primary colorectal cancer NOTE: *If the patient has a second malignancy with liver metastasis potential, histologic or cytologic confirmation of the liver lesions may be performed as clinically indicated
Liver-only or liver-predominant disease with any of the following:
- Unresected primary disease
- Limited bone or lung disease
- Potentially resectable nodal disease
- Anastomotic disease
- No active CNS metastasis or diffuse peritoneal metastasis
- No hepatic metastases from a second malignancy
- No predominant extrahepatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- WBC ≥ 1,500/mm^3
- Creatinine ≤ 2 mg/dL
- Bilirubin ≤ 2 mg/dL (without extrahepatic biliary obstruction)
- Albumin > 2 g/dL
- INR < 1.5 (without anticoagulation)
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior external-beam radiotherapy to the liver
- Concurrent targeted therapy agents (e.g., bevacizumab or cetuximab) allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408551
Locations
| United States, Indiana | |
| Center for Cancer Care at Goshen General Hospital | Recruiting |
| Goshen, Indiana, United States, 46526 | |
| Contact: Clinical Trials Office - Center for Cancer Care at Goshen Gene 574-535-2858 | |
Sponsors and Collaborators
Goshen Health System
Investigators
| Study Chair: | Kenneth L. Pennington, MD | Goshen Health System |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kenneth Lee Pennington, Center for Cancer Care at Goshen General Hospital |
| ClinicalTrials.gov Identifier: | NCT00408551 History of Changes |
| Other Study ID Numbers: | CDR0000515900, CCCGHS-CHEMO-SIRT |
| Study First Received: | December 6, 2006 |
| Last Updated: | June 30, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer stage IV rectal cancer liver metastases recurrent colon cancer recurrent rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
Floxuridine Fluorouracil Oxaliplatin Irinotecan Camptothecin Leucovorin Levoleucovorin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013